Explanation

A concise timeline of the planned study visits, enrolment process, interventions, and assessments performed on participants can help to guide trial conduct and enable external review of participant burden and feasibility. These factors can also affect the decision of potential investigators and participants to join the trial (Item 20).(287)

A schematic diagram is highly recommended to efficiently present the overall schedule and time commitment for trial participants in each study group. Though various presentation formats exist, key information to convey includes the timing of each visit, starting from initial eligibility screening through to study close-out; time periods during which the trial intervention/comparator will be administered (including any run-ins and washout periods);(288) and the procedures and assessments performed at each visit (with reference to specific data collection forms, if relevant).

Figure 2 Participant schedule of enrolment, interventions, and assessments for a randomised trial of lumbar microdiscectomy and post-operative activity restrictionsa

STUDY PERIOD

Enrolment

Allocation

Follow up

Close-out

TIMEPOINT

Post-clinic review

Pre-operative

Pre-operative survey

Day 1

1 month

3 months

6 months

12 Months

ENROLMENT:

Eligibility screen

X

Informed consent

X

Allocation

X

INTERVENTIONS:

[No post-operative activity restrictions group]

[Comparator group]

ASSESSMENTS:

[Pre-operative survey]

X

[Clinical review]

X

X

X

X

[Post-operative surveys]

X

X

X

X

X

aBased on(286)

Summary of key elements to address

Schematic diagram outlining the schedule and time commitment for trial participants, including:

● Timeline of trial visits starting from eligibility screening to trial close-out

● Timeline of interventions including any run-in and washout periods

● Procedures and assessments performed at each visit, referencing specific data collection forms, if relevant